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Fast freeze - Medication Information

Product NDC Code 66902-001
Drug Name

Fast freeze

Type Brand
Active Ingredients
Camphor (natural) 2 mg/g
Menthol 100 mg/g
Route TOPICAL
Dosage Form SPRAY
RxCUI drug identifier 1232160,
1232165
Application Number part348
Labeler Name Natural Essentials Inc.
Packages
Package NDC Code Description
66902-001-04 1 g in 1 bottle, pump (66902-001-04)
66902-001-16 1 g in 1 bottle, pump (66902-001-16)
66902-001-27 1 g in 1 bottle, pump (66902-001-27)
66902-001-44 1 g in 1 can (66902-001-44)
Check if available Online

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Camphor 0.2%, Menthol 10%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Adults/Children 2 years and older: Spray on the affected area not more than 3 to 4 times daily Shake well before use Children under 2 years old: Consult a physician.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Aloe Barbadensis (Aloe Vera) Leaf Extract, Ilex Paraguariensis Leaf Extract, SDA-39c Alcohol, Tocopherol (Vitamin E) Acetate, Water

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses Temporary relief of minor aches and pains of muscles and joints associated with: Simple backache Arthritis Strains Sprains

Purpose

Information about the drug product’s indications for use.
Purpose Cooling Pain Relief

Spl product data elements

Usually a list of ingredients in a drug product.
Fast Freeze CAMPHOR (NATURAL), MENTHOL CAMPHOR (NATURAL) CAMPHOR (NATURAL) MENTHOL MENTHOL ALOE VERA LEAF CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) ILEX PARAGUARIENSIS LEAF ISOPROPYL ALCOHOL METHYLPARABEN ALPHA-TOCOPHEROL ACETATE TROLAMINE WATER

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel – Can Label EASY ONE-TOUCH SPRAY RELIEF NEW! BELL-HORN FAST FREEZE ® PAIN RELIEVING CONTINUOUS SPRAY FREEZES PAIN INSTANTLY! HELPS TO RELIEVE: - SORE MUSCLES - STRAINS & SPRAINS - JOINT PAIN (GREAT FOR ARTHRISTIS) 4 oz (118 mL) Principal Display Panel – Can Label

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts Other information Replace cap after use Store in a cool, dry place

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you Have sensitive skin Are pregnant or breastfeeding

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use With heating pad or device With ointments, creams, sprays or liniments On wounds, damaged skin or irritated skin

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? Call 317-228-1144 or visit www.Bell-Horn.com or www.fastfreeze.com

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if Condition worsens Symptoms persist for more than 7 days or clear up then reoccur again within a few days Irritation develops

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product Avoid contact with eyes or mucous membranes Do not bandage tightly

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only Flammable Keep away from excessive heat or open flame Contents under pressure. Do not puncture or incinerate container. Do not expose to temperature exceeding 120°F (48°C) Do not use With heating pad or device With ointments, creams, sprays or liniments On wounds, damaged skin or irritated skin Ask a doctor before use if you Have sensitive skin Are pregnant or breastfeeding When using this product Avoid contact with eyes or mucous membranes Do not bandage tightly Stop use and ask a doctor if Condition worsens Symptoms persist for more than 7 days or clear up then reoccur again within a few days Irritation develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API